First-in-man Sirolimus-eluting Prolim® Stent Registry

September 12, 2015 updated by: Jacek Bil, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Novel Sirolimus-eluting Stent Prolim® With a Biodegradable Polymer in the All-comers Population

The aim of this study was to assess the safety and the efficacy of the novel sirolimus-eluting Prolim® stent with a biodegradable polymer in the all-comers population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Investigators prospectively enrolled all patients with stable coronary artery disease or acute coronary syndrome, treated with Prolim® stent between January and December 2013 in two interventional cardiology centers in Poland. Angiographic control was planned at 12 months, in which 15% of patients (randomly chosen) underwent optical coherence tomography analysis. The primary end-point was the cumulative rate of cardiac death, myocardial infarction, and target lesion revascularization after 12 months.

Study Type

Interventional

Enrollment (Actual)

204

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 18 years old,
  • stable coronary artery disease (SCAD) or acute coronary syndrome (unstable angina - UA, non-ST elevation myocardial infarction - NSTEMI or ST-elevation myocardial infarction - STEMI) and
  • signed informed consent

Exclusion Criteria:

  • inability to take dual antiplatelet therapy for 12 months,
  • left ventricular ejection fraction ≤ 30%,
  • chronic total occlusions, and
  • in-stent restenosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prolim stent implantation
In patients with symptomatic coronary artery disease Prolim stent was implanted in coronary arteries
Device: Prolim stent deployment
Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint was the cumulative rate of major adverse cardiovascular events (MACE).
Time Frame: 12 months
consisting of cardiac death, myocardial infarction (MI) and clinically-driven target lesion revascularization (TLR)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.
Time Frame: 12 moths
Secondary endpoints included the rates of cardiac death, all-cause death, MI, TLR, TVR and stent thrombosis.
12 moths
Late lumen loss (LLL)
Time Frame: 12 moths
The value (in mm) of LLL assessed in qualitative coronary angiography (QCA)
12 moths
The percentage of covered struts assessed in optical coherence tomography (OCT)
Time Frame: 12 months
The percentage of covered struts assessed in OCT
12 months
The neointima volume assessed in OCT
Time Frame: 12 months
The neointima volume (in mm3) assessed in OCT
12 months
The device success rate
Time Frame: intraoperative
The percentage of Prolim stents successfully implanted.
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Investigators

  • Principal Investigator: Jacek Bil, MD, PhD, Central Clinical Hospital of the Ministry of Internal Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 30, 2015

First Submitted That Met QC Criteria

September 9, 2015

First Posted (Estimate)

September 10, 2015

Study Record Updates

Last Update Posted (Estimate)

September 15, 2015

Last Update Submitted That Met QC Criteria

September 12, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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